View clinical trials related to Leukemia.
Filter by:This is a Phase Ib study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL)
Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..
The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a novel highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML). The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily. Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of at least 2 recommended dose levels for expansion selected from Part 1. In both Part 1 and Part 2, participants will receive continuous daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2, C1D8, C1D15, and C1D16, followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter. Approximately 60 to 80 participants could be enrolled in this trial, including approximately 24 to 36 participants in Part 1 (dose escalation), including optional backfill cohorts, and approximately 40 participants in Part 2 (randomized dose expansion). All participants will receive active trial intervention. Up to 4 dose-level cohorts may be evaluated in Part 1; at least 2 dose levels may be evaluated in Part 2.
The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).
1. Assess possibility of prediction of blood stream infections in ALL patients by profiling of NK cells using flow cytometry. 2. Assess the role of NK cells in development of drug resistance post chemotherapy.
This is a phase 1/2 trial of pacritinib in combination with azacitidine in patients with Chronic Myelomonocytic Leukemia (CMML). Patients will be newly diagnosed or previously treated but could not have received a prior JAK inhibitor. Patients who have previously been treated with a hypomethylating agent (HMA) must have received ≤ 1 cycle. Pacritinib will be initially tested at a dose of 200mg twice daily (dose level 0) in combination with azacitidine 75mg/m2, which can be administered subcutaneously or intravenously, for 7 days in a 28-day cycle. If there are 2 DLTs in the first 6 patients, there will be a dose escalation to pacritinib 100mg twice daily (dose level -1) and an additional 6 patients will be enrolled. Based on the phase 1, 3+3 dose de-escalation design, 6-12 patients will be enrolled in the phase 1 portion. After the completion of phase 1 and identification of the recommended phase 2 dose (RP2D), the trial will then proceed to phase 2 which will employ a Simon two stage design. This portion will include the 6 patients enrolled during the phase 1 portion at the MTD. An interim analysis for futility will occur. If 3 or fewer patients have had a clinical benefit (CB) or better, as defined by 2015 MDS/MPN IWG criteria, the PI and DSMC will meet to discuss the totality of the evidence and determine if the trial shall proceed. In the second stage, an additional 12 patients will be enrolled.
This phase I/II pilot study aims to enhance the effectiveness of stem cell transplant for children and young adults with high-risk acute myeloid leukemia (AML). Patients will undergo a stem cell transplant from a half-matched family donor. One week later, patients will receive an additional infusion of immune cells and a drug called interleukin-2. To mitigate the potential complications associated with graft-versus-host-disease, the donated stem cell product undergoes a process that removes a specific type of immune cell. After transplant, recipients are administered additional immune cells known as memory-like natural killer (ML NK) cells. These cells are derived by converting conventional natural killer cells obtained from the donor. The infusion of a modified stem cell product, along with administration of ML NK cells may help prevent the development of GvHD while simultaneously improving the efficacy of the treatment.
The purpose of this study is to see the effects of an investigational combination treatment of venetoclax, azacitidine, and donor lymphocyte infusion (DLI) in patients with high-risk AML receiving allogeneic hematopoietic cell transplantation, and to assess if the combination treatment is well tolerated and prevents disease relapse after transplant.
To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort
The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML). Names of the study therapies involved in this study are: - Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion - CIML NK (a cellular therapy) - IL-2 (a recombinant, human glycoprotein) - Venetoclax (a selective inhibitor of BCL-2 protein)